Company* |
Product |
Description |
Indication |
Status (Date) |
| | ||||
AUTOIMMUNE | ||||
Biogen Inc. |
Avonex (FDA- |
Interferon beta-1a |
Multiple sclerosis |
Company said eight years of data showed Avonex produced lower levels of neutralizing antibodies than Serono's Rebif (5/30) |
|
||||
BioMs Medical |
MBP8298 |
Intravenously injected peptide technology |
Multiple sclerosis |
Phase II data showed that a subset of patients had good results and the company is talking about starting a pivotal trial (5/23) |
|
||||
CellGate Inc.* |
PsorBan |
A topical cyclosporine conjugate |
Mild to moderate plaque psoriasis |
Phase IIa data showed a high dose exhibited benefits over placebo in both psoriasis severity score and physician treatment preference scores (5/2) |
|
||||
Enzo Biochem |
-- |
A complex of autologous colon-specific antigens administered orally |
Crohn's disease |
Phase I data showed that all 10 subjects had a clinical response to treatment, with seven achieving clinical remission (5/20) |
|
||||
Genentech Inc. |
Raptiva |
Efalizumab; recombinant humanized monoclonal antibody |
Moderate to severe rheumatoid arthritis |
Companies stopped Phase II testing after anevaluation suggested there was no efficacy (5/12) |
|
||||
Genmab A/S |
HuMax-CD4 |
Antibody that targets the CD4 receptor on T lymphocytes |
Psoriasis |
Company completed accrual in a Phase IIb trial (5/15) |
|
||||
Medarex Inc. (MEDX) and Novartis Pharma AG (Switzerland) |
-- |
Antibody created with Medarex's UltiMAb Human Antibody Development System |
Autoimmune disease |
Novartis began Phase I trials (5/6) |
|
||||
Serono SA |
Rebif (FDA-approved) |
Interferon beta-1a |
Multiple sclerosis |
Company released data showing Rebif was more effective in reducing the frequency of relapses over the course of a 63-week study when compared to Biogen's Avonex (5/30) |
|
||||
Vertex |
VX-148 |
A second-generation IMPDH inhibitor |
Moderate to severe psoriasis |
Company completed enrollment in a Phase II trial (5/21) |
|
|
|||
CANCER | ||||
Agennix Inc.* |
-- |
Recombinant human lactoferrin, a protein found naturally in milk and other exocrine secretions |
Solid tumors |
Company completed the safety portions of two Phase I/II cancer trials (5/23) |
|
||||
Allos Therapeutics |
RSR13 |
Efaproxiral; synthetic small molecule |
Breast cancer |
Phase III data showed a statistically significant improvement in median survival; the company plans to file an NDA (5/29) |
|
||||
AnorMED Inc. |
AMD-3100 |
Designed to block the CXCR4 chemokine receptor |
Multiple |
Company began a second Phase II trial (5/23) |
|
||||
Ariad Pharmaceuticals |
AP23573 |
Cancer drug that inhibits the protein mTOR and shrinks tumors by cancer cell starvation through inhibition of growth factor stimulation |
Cancer |
Company began enrollment in two Phase I studies (5/7) |
|
||||
Celgene Corp. |
Revimid |
A small-molecule compound that modulates the immune system |
Anemia in myelodysplastic syndrome |
Phase I/II data showed patients were able to reduce or entirely eliminate red blood cell transfusions that previously were required to manage their condition (5/16) |
|
||||
Celgene Corp. |
Thalomid |
Thalidomide; modulates levels |
Multiple |
Phase II data showed that the 17 patients who received Thalomid did not experience grade three or four neutropenia or thrombocytopenia, while 70% of patients receiving high-dose cyclophosphamide with VAD by continous infusion experienced thrombocytopenia, and all 50 of them experienced neutropenia (5/28) |
|
||||
Cell |
Trisenox (FDA-approved) |
Arsenic trioxide |
Multiple |
Clinical data showed Trisenox produced objective responses in 31 of the 78 evaluable patients who were chemotherapy resistant (5/27) |
|
||||
Celsion Corp. (AMEX:CLN) |
Thermodox |
Microfocus BPH800 Urethroplasty System provides the heat required to trigger the release of the chemotherapeutic agent |
Prostate cancer |
Company treated the first patient in a Phase I trial (5/29) |
|
||||
ChemGenex |
Quinamed |
Amonafide |
Solid tumor cancers |
Company completed patient enrollment in the first part of a Phase I/II trial (5/15) |
|
||||
Genentech Inc. |
Avastin |
Bevacizumab, an antibody directed at vascular endothelial growth factor |
Metastatic colorectal cancer |
Phase III data showed the drug met its primary endpoint of improving overall survival and hit secondary endpoints of progression-free survival, response rates and duration of response (5/19) |
|
||||
Genta Inc. |
Genasense |
Oblimersen sodium; antisense compound geared toward blocking the production Bcl-2 |
Multiple |
Phase I/II data of 15 evaluable patients showed three patients achieved a complete or near-complete response, and five patients achieved a partial response, for an overall response rate of 53% (5/27) |
|
||||
Hybridon Inc. |
HYB2055 |
Second-generation immunomodulatory oligonucleotide |
Malignant |
Company initiated a Phase I trial (5/19) |
|
|
|||
Milkhaus |
ML-04 |
Human chorionic gonadotropin |
Benign prostatic hyperplasia |
Company completed enrollment in a Phase IIb trial (5/1) |
|
||||
Onyvax Ltd.* |
Onyvax-P |
Cancer vaccine consisting of three inactivated cell lines that target a range of prostate cancer-associated antigens |
Prostate cancer |
Phase IIa data demonstrated an immune response with a statistically significant decrease in the rate of prostate-specific antigen release (5/6) |
|
||||
Oxford |
TroVax |
Targets the tumor antigen 5T4; gene therapy |
Renal cancer |
Company started a Phase II trial in the U.S. (5/28**) |
|
||||
PharmaMar* (Spain; division of the Zeltia Group) |
Kahalalide F |
An antitumor agent derived from the sea slug, Elysia rufescens |
Liver cancer |
Company entered Phase II trials (5/29) |
|
|
|||
Pharmexa A/S |
HER-2 Protein AutoVac |
Product that uses the AutoVac technology, which aims to induce a strong but controlled antibody response against harmful self-antigens to reduce their levels |
Breast cancer |
Company will begin a Phase I trial (5/14**) |
|
||||
Point |
PT-100 |
Orally active small molecule, which stimulates the proliferation of hematopoietic progenitor cells and the differentiation of neutrophils |
Severe neutropenia associated with chemotherapy |
Clinical results showed an improvement in severe neutropenia, and the therapy was well tolerated (5/28) |
|
||||
Pro- |
Davant |
Glyco-upgrade drug that targets sugar-specific binding sites found on cancer cells using carbohydrate technology |
Advanced solid tumors |
Company began dosing patients in a Phase I trial (5/14) |
|
||||
QLT Inc. (Canada; QLTI) and Xenova Group plc (UK; XNVA) |
Tariquidar |
P-glycoprotein membrane inhibitor |
Non-small-cell lung cancer |
Companies halted Phase III trials after an independent safety committee brought up toxicity issues (5/13) |
|
||||
Vion Pharmaceuticals |
Triapine |
Inhibitor of ribonucleotide reductase |
Non-small-cell lung cancer |
Company began a Phase II trial (5/21) |
|
||||
Vion Pharmaceuticals |
Triapine |
Inhibitor of ribonucleotide reductase |
Pancreatic |
Company initiated a Phase II trial (5/28) |
|
||||
CARDIOVASCULAR | ||||
Actelion Ltd. (Switzerland; SWX:ATLN) |
Tracleer (FDA-approved) |
Oral dual endothelin receptor antagonist |
Pulmonary hypertension |
Clinical data suggested that the use of Tracleer is associated with improved survival (5/20) |
|
||||
Centocor Inc. (unit of Johnson & Johnson) |
ReoPro (FDA-approved) |
Abciximab, an anticlotting agent |
Acute ischemic stroke |
Phase IIb results showed ReoPro improves the recovery of patients when administered up to six hours after stroke onset (5/23) |
|
||||
Encysive Pharmaceuticals (ENCY; formerly Texas Biotechnology Corp.) |
Sitaxsentan |
Endothelin receptor antagonist |
Pulmonary arterial hypertension |
A Phase IIb/III trial found that sitaxsentan 100-mg and 300 mg provided clinical benefit in those patients, while the 100-mg dose was better tolerated (5/20) |
|
||||
InterMune Inc. |
Actimmune (FDA-approved) |
Interferon gamma-1b |
Idiopathic pulmonary |
Phase III data failed to show a significant treatment effect on the primary endpoint, but did suggest a survival benefit in the intent-to-treat population (5/19) |
|
||||
InterMune |
Pirfenidone |
Orally active small molecule drug that appears to inhibit collagen synthesis, downregulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines |
Idiopathic pulmonary fibrosis |
Phase II data suggests the drug may be more efficacious than prednisone in patients with idiopathic pulmonary fibrosis (5/9) |
|
||||
NicOx SA |
NCX 4016 |
Nitric oxide-donating derivative of aspirin |
Cardiovascular diseases |
Clinical data showed gastro protection of NCX 4016 even when it was co-administered with celecoxib (5/21) |
|
||||
United Therapeutics Corp. (UTHR) |
Remodulin (FDA-approved) |
Treprostinil sodium injection |
Pulmonary arterial hypertension |
Clinical data showed statistically significant reductions in pulmonary vascular resistance, and patients experienced other clinically significant improvements in their hemodynamic measurements and exercise capacity (5/21) |
|
||||
ThromboGenics |
Microplasmin |
A thrombolytic agent |
Thromboembolic diseases |
Company completed a Phase I trial showing it was safe and well tolerated (5/23) |
|
||||
CENTRAL NERVOUS SYSTEM | ||||
Cephalon Inc. |
Provigil (FDA-approved) |
Modafinil tablets; oral formulation of the synthetic compound |
Attention deficit hyperactivity disorder |
Phase II data showed that Provigil improves attention deficit hyper-activity disorder symptoms in children in both school and home settings and is well tolerated (5/21) |
|
||||
Cypress |
Milnacipran |
The first of a new class of agents known as NSRIs, or norepinephrine serotonin reuptake inhibitors |
Fibromyalgia syndrome |
Phase II data demonstrated the safety and efficacy of milnacipran (5/29) |
|
||||
Neurocrine |
Indiplon |
Capsules; acts on the GABA-A receptor |
Insomnia |
The drug showed no evidence of rebound insomnia or withdrawal in a Phase III trial with two doses (5/19); Phase II data showed the primary endpoint of latency to persistent sleep was met (5/22) |
|
||||
NicOx SA |
HCT 1026 |
Nitric oxide-donating derivative of flurbiprofen |
Alzheimer's disease |
Phase I data showed penetration of the blood-brain barrier and the presence of effective drug concentrations in the cerebrospinal fluid after repeated oral dosing (5/13) |
|
||||
Phytopharm plc |
PYM50028 |
Orally active synthetic neuroprotective and neuroregenerative |
Parkinson's disease |
Company completed a Phase I trial that showed a good safety profile (5/28**) |
|
|
|||
Repligen |
RG1068 |
Synthetic human secretin |
Schizophrenia |
Company began a Phase II trial (5/14) |
DIABETES | ||||
Altea Therapeutics Corp.* |
ATI391 |
A daily insulin patch |
Diabetes |
Company began Phase I trials (5/28) |
|
||||
Amylin Pharmaceuticals Inc. (AMLN) |
Symlin |
Pramlintide acetate; an analogue of human amylin, a hormone secreted with insulin by the beta cells in the pancreas |
Diabetes |
Clinical data in a 296-patient study showed Symlin-treated subjects used 12% less insulin overall compared to control (5/19) |
|
||||
ConjuChem Inc. |
DAC:GLP-1 |
Derived from the human hormone glucagon-like peptide 1 (7-36)-amide; it is engineered into a drug construct using DAC technology |
Type II diabetes |
Company plans to begin a Phase I/II trial in the U.S. (5/9) |
|
||||
Emisphere Technologies Inc. (EMIS) |
-- |
Oral insulin formulation that uses Emisphere's eligen oral drug delivery technology to deliver the insulin in a capsule |
Type II diabetes |
Company began a 12-patient trial (5/8) |
|
||||
Forest Laboratories |
Memantine |
A moderate-affinity, uncompetitive N-methyl D-aspartate receptor antagonist that modulates glutamate levels |
Neuropathic pain in diabetes patients |
A pivotal trial failed, showing the drug did not demonstrate a significant difference vs. placebo relative to the trial's primary endpoints (5/7) |
|
||||
Isis |
ISIS 113715 |
Second-generation antisense drug designed to improve defective insulin signaling by targeting PTP-1B |
Type II diabetes |
Company initiated a Phase I trial (5/14) |
|
||||
INFECTION | ||||
Access Pharmaceuticals Inc. (AMEX:AKC) |
OraDisc A |
A mucoadhesive disc containing amlexanox |
Canker sores |
Phase III data showed OraDisc A achieved its primary endpoint (5/27) |
|
||||
AM-Pharma Holding BV* (the Netherlands) |
-- |
Alkaline phosphatase |
Sepsis |
Company completed a Phase I trial and a Phase IIa trial (5/8) |
|
||||
Cubist |
CAB-175 |
Cephalosporin |
Streptococcus pneumoniae and Staphylococcus aureus infection |
Phase I data showed that a single dose up to 1,000 mg was tolerated by normal, healthy male subjects (5/13) |
|
|
|||
ID Biomedical |
FluINsure |
Intranasal influenza |
Influenza |
Clinical results showed positive results for both safety and the potential endpoints of the study (5/1) |
|
||||
ID Biomedical |
StreptAvax |
A multivalent alum-adjuvanted vaccine containing recombinant proteins representing coverage for 26 significant serotypes of group A streptococci |
Group A streptococci |
Phase II data showed that StreptAvax vaccine's immunogenicity was significant and generated antibody responses (5/6) |
|
||||
Immtech International Inc. (OTC BB:IMMT) |
DB289 |
Oral anti-infective; dicationic pharmaceutical compound |
Penumocystis carinii pneumonia |
Company began a Phase IIb trial (5/27) |
|
||||
Inhibitex Inc.* |
Veronate |
Antibody-based product that belongs to a class of drugs referred to as immune globulins |
To prevent staphylococcal infections in low-birth-weight infants |
Phase I data showed it was well tolerated at lower dose levels (5/6) |
|
||||
InterMune Inc. |
Infergen (FDA-approved) |
Interferon alfacon-1 |
Chronic hepatitis C |
Clinical data showed that more than half of patients who didn't respond to pegylated interferon and ribavirin responded to Infergen (5/20) |
|
||||
Isis Pharmaceuticals Inc. (ISIS) |
ISIS 14803 |
Antisense drug; 20-base phosphorothioate oligo- nucleotide |
Hepatitis C |
Company initiated a Phase II trial (5/29) |
|
||||
Ribapharm Inc. (NYSE:RNA) |
Hepavir B |
A nucleoside analogue |
Hepatitis B |
Company began a Phase I trial (5/2) |
|
||||
Sunol Molecular |
-- |
An antibody designed to neutralize one of the two Shiga toxins released by E. coli strains during infection |
E. coli infection |
Company began a Phase I trial (5/6) |
|
||||
The Immune |
Remune |
HIV-1 immunogen |
HIV |
Clinical results showed that vaccination with Remune increased HIV-1-specific immune response in chronic HIV patients receiving suppressive antiretroviral therapy (5/19) |
|
||||
Theratechnologies |
ThGRF |
Growth hormone-releasing factor analogue |
HIV-related lipodystrophy |
Company enrolled the first patient in a Phase II trial (5/22) |
|
||||
Vicuron Pharmaceuticals Inc. (MICU) |
Anidulafungin |
Antifungal agent; member of the echinocandin class |
Candidiasis/candidemia |
Phase II data showed efficacy and that anidulafungin was well tolerated (5/13) |
|
||||
MISCELLANEOUS | ||||
Altus |
TheraCLEC |
Enzyme replacement therapy |
Malabsorption as a result of pancreatic insufficiency |
Phase I data showed it was safe and well tolerated (5/14) |
|
||||
BioBalance |
-- |
A non-pathogenic strain of E. coli Probiotic oral suspension |
Inflammatory bowel disease |
The strain appeared to relieve the major clinical symptoms of inflammatory bowel disease in a pilot trial (5/20) |
|
||||
BioSante Pharmaceuticals Inc. (OTC BB:BISP) |
Bio-E-Gel |
Estradiol topical gel |
Moderate to severe hot flashes in menopausal women |
Phase II/III data pointed to an effective dose of Bio-E-Gel (5/7) |
|
||||
Biovitrum AB* (Sweden) and laxoSmithKline plc (UK) |
BVT.933 |
A 5-HT2c receptor agonist |
Obesity |
Companies agreed to halt a Phase IIb study in order to focus on more highly selective compounds (5/22) |
|
||||
Cell Therapeutics Inc. (CTIC) |
Trisenox |
Arsenic trioxide injection |
Myelodysplasia |
Clinical data suggest Trisenox could be active and well tolerated against the disease (5/19) |
|
||||
DrugAbuse |
Naltrexone Depot |
A once-per-month injection of naltrexone |
Alcoholism |
Phase III data showed that by 12 months patients experienced 73% more drink-free days than the placebo-group counterparts (5/5) |
|
||||
Genaera Corp. |
Squalamine |
Angiogenesis inhibitor that blocks a number of angiogenic growth factors, including vascular endothelial growth factor |
Age-related macular degeneration |
Phase I/II data showed evidence of activity such as shrinkage of the size of the choroidal neovascularization lesions associated with age-related macular degeneration (5/9) |
|
||||
Genzyme General (GENZ) |
Myozyme |
Recombinant human acid alpha-glucosidase enzyme |
Pompe disease |
Genzyme treated the first patient in a pivotal clinical trial (5/29) |
|
||||
Inspire |
INS37217 |
A non-preserved nasal spray formulation |
Allergic rhinitis |
Phase III data failed to meet the primary endpoint as the product did not significantly reduce the total nasal symptom score over the 28-day treatment period against placebo (5/20) |
|
||||
Isis Pharmaceuticals Inc. (ISIS) |
ISIS 2302 |
Antisense inhibitor of the inflammatory target intercellular adhesion molecule-1 |
Inflammatory bowel disease |
Phase II data showed improvements in endoscopic scores, suggesting a long-term benefit of ICAM-1 inhibition (5/21) |
|
||||
Millennium Pharmaceuticals Inc. (MLNM) |
MLN02 |
Monoclonal antibody |
Ulcerative colitis |
Phase II data showed statistically significant improvements in the clinical remission rates of patients treated with MLN02, compared to placebo (5/22) |
|
||||
Nastech Pharmaceutical Co. Inc. (NSTK) |
Apomorphine |
Intranasal formulation; a potent dopamine agonist |
Female sexual dysfunction |
Phase II data showed that 55% of women treated had improvement in satisfaction with sexual activity (5/29) |
|
||||
Oculex |
Posurdex |
Biodegradable microsized drug delivery system designed to provide continuous drug therapy for about one month inside the eye |
Persistent macular edema |
Phase II data suggested that Posurdex improves vision in patients with persistent macular edema (5/8) |
|
||||
Pain Therapeutics Inc. (PTIE) |
PTI-901 |
Opioid antagonist |
Irritable bowel syndrome |
Clinical data showed the drug significantly improved all of the common symptoms associated with irritable bowel syndrome (5/29) |
|
||||
Palatin Technologies Inc. (AMEX:PTN) |
PT-141 |
Peptide analogue of (alpha)-MSH ([alpha]-melanocyte- |
Erectile |
Company began enrolling patients in a Phase IIb study (5/13) |
|
||||
Progenics Pharmaceuticals Inc. (PGNX) |
MNTX |
Methylnaltrexone; designed to reverse the side effects of opioids without interfering with pain relief |
Post-operative ileus |
Company began a Phase II trial (5/13) |
|
||||
Protein Design Labs Inc. (PDLI) |
Nuvance |
Anti-interleukin-4 antibody |
Asthma |
Product failed to show clinical benefit in a Phase IIa trial; the company is stopping development (5/8) |
|
||||
Regeneron Pharmaceuticals Inc. (REGN) |
Axokine |
A genetically re-engineered version of ciliary neurotrophic factor |
Obesity |
Phase III data showed certain obese patients lost up to 7% of their body weight after a year (5/19) |
|
||||
Repligen Corp. (RGEN) |
SecreFlo (FDA-approved) |
A synthetic porcine secretin for injection |
Pancreatitis |
Trial results demonstrated that SecreFlo reduced the incidence of pancreatitis following endoscopic retrograde cholangiopan- creatography (5/22) |
|
||||
Sucampo Pharmaceuticals Inc.* |
SPI-0211 |
A chloride channel activator |
Constipation |
Phase III data demonstrated SPI-0211 performed significantly better than placebo for all constipation variables tested (5/20) |
|
||||
| | ||||
Notes: | ||||
* Privately held | ||||
** Denotes the date the item ran in BioWorld International. | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; CSE = Copenhagen Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; OTC BB = Over-the-Counter Bulletin Board; SWX = Swiss Stock Exchange; TSE = Toronto Stock Exchange. | ||||
